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Chemotherapy and Radiation Therapy in Treating Patients With Stage III or Stage IV Head and Neck Cancer

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Disease Information

Descriptive Information
Brief Title † Chemotherapy and Radiation Therapy in Treating Patients With Stage III or Stage IV Head and Neck Cancer
Official Title † Taxotere Plus Concurrent Concomitant Boost Radiotherapy For Squamous Cell Cancer of the Head and Neck (TAXT-XRT)
Brief Summary Phase I trial to study the effectiveness of docetaxel plus radiation therapy in treating patients who have stage III or stage IV head and neck cancer.
Detailed Description OBJECTIVES: - Determine the maximum tolerated dose of docetaxel when administered with concurrent boost radiotherapy in patients with advanced squamous cell carcinoma of the head and neck previously treated with induction chemotherapy. - Determine the toxicity of this treatment regimen in this patient population. - Determine the efficacy of this treatment regimen in these patients. OUTLINE: This is a dose escalation study of docetaxel. Patients receive docetaxel IV over 1 hour weekly for 4 weeks. Patients also undergo hyperfractionated radiotherapy daily, 5 days a week, for 4 weeks followed by radiotherapy alone twice daily for 2 weeks. Upon completion of chemoradiotherapy, patients not achieving complete response to induction chemotherapy undergo neck surgical dissection at 4-12 weeks following completion of radiotherapy. Cohorts of 3-5 patients receive escalating doses of docetaxel until the maximum tolerated dose (MTD) is reached. The MTD is the dose preceding that at which 2 of 3 or 2 of 5 patients experience dose limiting toxicity. Additional patients are treated at the MTD. Patients are followed monthly for 1 year, and then annually thereafter. PROJECTED ACCRUAL: A total of 18-25 patients will be accrued for this study.
Study Phase Phase 1
Study Type † Interventional
Study Design †
Primary Outcome Measure † MTD of Taxotere
Secondary Outcome Measure † Overall Response Rate
Condition † Head and Neck Cancer
Intervention † DrugTaxotere
Study Arms / Comparison Groups Taxotere Taxotere: (1 hour infusion once a week for four weeks) Radiation Therapy (5 days/week for 6-7 weeks) Surgery (if required) 14 -12 weeks after radiotherapy Follow-up
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Drug
Estimated Enrollment † 31
Start Date † July 14, 2000
Completion Date July 3, 2004
Primary Completion Date July 17, 2003
Eligibility Criteria † Inclusion Criteria: - Pathology: -- Histologic documentation of squamous cell carcinoma of the head and neck or its variants (lymphoepithelioma, undifferentiated epidermoid carcinoma, etc.). - Stage: -- Patients will be entered on this protocol after initial induction therapy, if, prior to the induction regimen, they were previously untreated Stage III or IV (MO) SCCHN. Evaluable disease during induction therapy is required. - Required Prior Therapy: Patients entered on this protocol will have received platinum/FUra based induction chemotherapy. They may have received a taxane as part of this plan. - Patients treated with induction are eligible provided that they receive no more than 3 cycles of chemotherapy, but at least one cycle of chemotherapy, and are less then 7 weeks from the start of last cycle of induction therapy. - Other Malignancies: - Patients with previous head and neck cancer are ineligible, except patients who were treated with surgery as the sole modality ≥2 years prior to study entry. - Patients with concurrent malignancy of any site, except limited basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix are ineligible. - Patients with any non-SCCHN malignancy within 3 years of study entry, except curatively treated basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix are ineligible. - Other Prior Therapy: - Patients treated with induction therapy - Hormonally treated patients are eligible. - Performance: Patients must meet the following performance criteria: - Performance status: ≤2 (ECOG) Complete recovery from previous diagnostic or therapeutic procedures is required. - Nutritional Status: Adequate and nutritionally balanced enteral intake ≥ 1,800 kcal/day). - A PEG is required prior to initiation of radiation. - Age: ≥18 years - Life Expectancy: Longer than 3 months. - Women of child bearing potential must not be pregnant by history or lactating at the time of entry on this protocol and men and women of child bearing potential must be requested to use an accepted and effective method of birth control during therapy. - Organ Function: Biochemical and hematological parameters (obtained within 2 weeks of study entry) as follows: - Hepatic: SGOT
Gender All
Ages 18 Years - N/A
Accepts Healthy Volunteers No
Contacts ††
Location Countries † United States
Administrative Information
NCT ID † NCT00006107
Organization ID 99-274
Secondary IDs †† P30CA006516, NCI-G00-1833
Responsible Party Principal Investigator
Study Sponsor † Dana-Farber Cancer Institute
Collaborators †† National Cancer Institute (NCI)
Investigators † Principal Investigator: Roy B. Tishler, MD, PhD, Dana-Farber Cancer Institute
Information Provided By
Verification Date June 2017
First Received Date † August 3, 2000
Last Updated Date June 15, 2017
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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